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Recall Observatory FDA recall evidence

Device product

Safeline Y-Type Blood Set, Catalog Number V2500

Z-0941-2020

November 20, 2019

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 84365
Status
Terminated
Classification
Class II
Quantity
19,500 units
Official record key
device-enforcement:Z-0941-2020

Official wording

Reason: Potential for leakage at the joint between the blood filters and tubing

Code information: GUIDID: 04046964188633 Lot Numbers: 61674884 - Expiration Date: April 30, 2024, 61677634 - Expiration Date: April 30, 2024, 61678262 - Expiration Date: May 31, 2024, 61680625 - Expiration Date: May 31, 2024, 61685110 - Expiration Date: June 30, 2024

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for leakage at the joint between the blood filters and tubing